Senior Manager, Content Strategy & Development (Medical Writing) - Protocol Lead

Job Description

Gilead Regulatory Affairs is a committed and proud team of highly skilled professionals dedicated to helping deliver therapies in the most efficient and effective way to patients with unmet medical need around the world. We bring our passion for science, discovery, and innovative strategic thinking into everything we do. The Content Strategy & Development (CSD) department is part of Innovation, Content, & Execution (ICX) within Regulatory Affairs, and advances the strategy and creation of high-quality documents to support efficient and successful regulatory submissions.

We are an inclusive and diverse community, supported by strong leaders who are committed to providing individual development and growth opportunities while achieving our mission. Our collaborative and supportive structure help support work-life balance.

Responsibilities:

We have an exciting and unique opportunity for a regulatory medical writer to join our dynamic team at the Senior Manager level. You will have the opportunity to develop expertise in the preparation of a wide range of documents, with a focus on protocol development. You will work collaboratively within crossfunctional teams (eg, Regulatory Affairs, Clinical Development, Patient Safety, Biostatistics, Clinical Pharmacology, Clinical Operations) to lead protocol development for large clinical programs and drive document strategy. Direct experience in protocol authoring or management is highly preferred.

• Lead the development of protocols and amendments for CSD (Medical Writing) in the Oncology therapeutic area, including development and management of timelines and resource planning, supporting large clinical programs.

• Oversee internal and external medical writers on protocols and amendments to ensure the highest quality of medical writing and adherence to Gilead content and quality standards.

• Independently author a wide variety of clinical/regulatory documents such as protocols and amendments, ICFs, CSRs (all phases), and IBs according to regulatory requirements and internal Gilead document standards.

• Author high complexity documents such as integrated CTD summaries/overviews, PSPs, PIPs/PIP modifications, or regulatory responses with some input from a more senior CSD team member.

• Participate in development/improvement of document standards, templates, and processes and other non-medical writing activities.

• Excellent verbal communication skills. Can effectively communicate with a variety of teams and individuals.

• May coach, train, and provide mentoring and guidance to less experienced writers.

Basic Qualifications:

Bachelor's Degree and Eight Years’ Experience

OR

Masters' Degree and Six Years’ Experience

OR

Ph.D.

Preferred Qualifications:

• PharmD/PhD with 4+ years’ relevant experience.

• MA/MS/MPH/MBA 6+ years’ relevant experience.

• BA/BS with 8+ years’ relevant experience.

• Significant content strategy and development, regulatory, quality, clinical R&D, or related experience supporting medicinal products.

• Significant experience in the biopharma industry is strongly preferred.

• Experience authoring a broad range of regulatory, scientific, medical and other business content across multiple stages of drug development.

• Knowledge of AI and other emerging technologies to complete medical writing or related deliverables is preferred.

• Knowledgeable of regulatory document requirements/guidelines with direct experience in a wide variety of regulatory document types.

• Well-developed computer skills including proficiency in Word, Adobe, Excel, and the Regulatory Document Management System.

People Leader Accountabilities

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.

• Develop Talent - understand the skills, experience, aspirations, and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop, and realize their purpose.

• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.